WHO’s Access Roadmap And The Art Of Accommodation Of Pharma Interest 26/01/2019 by Intellectual Property Watch 1 Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) The views expressed in this article are solely those of the authors and are not associated with Intellectual Property Watch. IP-Watch expressly disclaims and refuses any responsibility or liability for the content, style or form of any posts made to this forum, which remain solely the responsibility of their authors. By K M Gopakumar [*] The Roadmap to access to medicines, vaccines and other health products (Roadmap) to be discussed at this week’s 144th session of WHO’s Executive Board accommodates vital interest of pharmaceutical TNCs on critical issues such as the approach to access, technical assistance on the use of TRIPS flexibilities and access to biosimilars. Access v Equitable Access The Roadmap anchoring two “interlinked Strategies” viz. “ensuring the quality, safety, and efficacy of health products” and improving equitable access to health products.” Unlike the human rights literature, which spells out the access to medicine without any qualification, the Roadmap qualifies it with the term “equitable.” Even though it sounds like persuading the devil is in the detail. The term equitable means fair and impartial. This could be used by the pharmaceutical industry to demand fair price, thereby justifying charging high prices in the middle-income countries. This is further articulated through the proposed deliverables under activity in the Roadmap called “evidence-based selection and fair and affordable pricing.” The Roadmap defines fair price as follows: “A “fair price” is one that is affordable for health systems and patients and that at the same time provides sufficient market incentives for industry to invest in innovation and the production of medicines”. As per the definition, fair price is different from the affordable price and it is a price reached taking into consideration the market incentive for industry to invest in innovation and the production of medicines. Thus the definition in effect means that prices of the medicines should not be as low as currently due to generic competition and it should compensate those involved in the research and development and manufacture of medicines. There is ample evidence that generic competition brings down the prices of medicine drastically. For instance, though the prices of Gilead’s Sofosbuvir price for a 12 week treatment is USD 84,000, Gilead offered the medicine to a few developing countries for USD 900 – almost 90% less than the market price. However, the generic competition often brought down the price below USD 100. The fair price initiative thus undermines the generic competition through the use of TRIPS flexibilities such as compulsory license and government use license and legitimizes a high price. Most importantly, it raises the question of fairness for whom? Till date, there is no transparency with regard to the cost of research and development. The cost of R&D is not open for public scrutiny and verification. The opaqueness around R&D cost has been used often to justify higher prices for patented medicines. The fair price to provide incentives to innovation would then legitimizes the high prices for medicines and compromises access to medicines in the many WHO Member States. Thus the term equitable access is furthering the Pharmaceutical TNC’s demand for high prices in the name of fair pricing. TRIPS Flexibilities Deliverables under the activity “application and management of intellectual property to contribute to innovation and promote public health ” propose the four deliverables. Out of the four deliverables, the following two are in collaboration with other international organizations. Technical support provided (as appropriate, upon request, in collaboration with other competent international organizations), including to policy processes and to countries that intend to make use of the provisions contained in TRIPS, such as the flexibilities recognized by the Doha Declaration on the TRIPS Agreement and Public Health and other WTO instruments related to TRIPS, in order to promote access to pharmaceutical products. Continued strengthening of the trilateral collaboration between WHO, WIPO, and WTO, including to implement this road map, as well as with other relevant international organizations such as UNCTAD and UNDP. The concern is related to the involvement of World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) in providing technical assistance to make use of TRIPS flexibilities and the implementation of the Roadmap because both WIPO and WTO follows a pro-patent approach. In the case of WIPO, the conflict of interest is so obvious. WIPO earns substantial revenue by facilitating the international filing of the patent application under the Patent Cooperation Treaty (PCT), therefore, possesses a vested interest to protect the interest of the patent holder than protecting the larger public interest. Therefore the involvement of WIPO and WTO could compromise the quality of technical assistance and the implementation of the Roadmap. Further, one of the deliverables under activity “evidence-based selection and fair and affordable pricing” list improving the capacity for price negotiation as one of the deliverables”. This, in fact, comes in conflict with the deliverables in activity related application and management of intellectual property to contribute to innovation and promote public health,” which proposes the technical assistance to make use of TRIPS flexibilities. In other words, it is not clear whether the Roadmap suggests price negotiations over the use of TRIPS flexibilities such as compulsory licenses. The evidence suggests that the use of a compulsory license could bring down the price lower than a negotiated price. Access to Biosimilars One of the deliverables under the regulatory system strengthening is: “Guidelines, standards and biological reference materials to support decreased regulatory burden and support production and quality control of safe and effective health products.” It is not clear that WHO is to revise the guidelines on marketing approval of biosimilars, which currently insists on comparative clinical trials. The comparative clinical trails make the development expensive and time-consuming and thus blocks access to bios-similars at an affordable price. The WHA 67.21 requested the Director-General “to convene the WHO’s Expert Committee on Biological standardization to update the 2009 guidelines, taking into account the technological advances for the characterization of biotherapeutic products and considering national regulatory needs and capacities and to report on the update to the Executive Board.” However, to date, there is no updating of the Guideline, while the new evidence supports the marketing approvals of a generic version of biotherapeutics without comparative clinical trials. Regulatory System Strengthening and Access Expansion of the prequalification program is stated as one of the deliverables to expand access. While prequalification offers an opportunity to market the medicine in multiple markets through a single marketing approval in its current form, it favors only big pharmaceutical companies. The expansion of prequalification thus favors big companies at the cost of small and medium companies. Lastly, there is no clarity about whether the activities related to regulatory system strengthening would lead to regulatory harmonization at the high threshold level for the regulatory approval of health products and would adversely impact the local production initiatives in developing countries. Adoption of the Roadmap in its current form very well accommodates the interest of the Pharmaceutical TNCs and therefore one need not expect any proactive steps by WHO towards promoting access after the adoption of the Roadmap. [*] K M Gopakumar is a Senior Researcher and Legal Advisor with Third World Network (TWN ). The views expressed in the article are the opinion of the author and do not necessarily reflect the opinion of TWN. 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